FDA Device recall Z-2455-2015
Offset Femoral Alignment Guide 4mm x 6¿
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of Offset Femoral Alignment Guide 4mm x 6¿ by Omnilife Science, citing the markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2455-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-09 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Omnilife Science |
| Distribution | US |
Product
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Reason
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Identifiers
| code_info | Lot Numbers: MM0314R, VA0713, Z1111 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2455-2015%22
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